Evidence map›Paper›PMID 31696314›Full record

ArticlePharmaceutical research2019

Functional and Nonclinical Similarity of ABP 980, a Biosimilar of Trastuzumab.

Shea Jassem, Wei Wang, Heather Sweet, Raffi Manoukian, Vincent Chow, Palanisamy Kanakaraj, Katariina M Hutterer, Scott Kuhns, Ian N Foltz, Qing Chen and 2 more

Open access · hybridAbstract read
In one paragraph

Article in Pharmaceutical research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 1 institution in 1 country.

Shea JassemAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA.
Wei WangAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA.
Heather SweetAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA.
Raffi ManoukianAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA.
Vincent ChowAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA.
Palanisamy KanakarajAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA.
Katariina M HuttererAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA.
Scott KuhnsAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA.
Ian N FoltzAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA.
Qing ChenAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA.
John FerbasAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA.
Helen J McBrideAmgen Inc, One Amgen Center Drive, Thousand Oaks, California, 91320, USA. hmcbride2000@gmail.com.
Amgen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe in vitro and in vivo pharmacologic assessment of ABP 980 similarity to its reference product is intended to compare the activity of ABP 980 and trastuzumab and support the overall conclusion of similarity based on a comprehensive analytical and functional evaluation.

methodsThis work complements the primary assessment of functional similarity with additional in vitro assays, binding studies, and non-clinical studies including human epidermal growth factor receptor-2 (HER2) kinetic binding, HER2 signaling, HER2 internalization, synergy with docetaxel chemotherapy, FcγR kinetic binding, primary natural killer and monocyte cell binding, antibody-dependent cellular phagocytosis activity, in vivo xenograft studies, and toxicokinetic parameters.

resultsThe results contribute to the totality of evidence with respect to functional similarity and support that ABP 980 is similar to trastuzumab in all primary and secondary mechanisms of action.

conclusionsThese results also support the scientific justification of extrapolation to all approved indications of trastuzumab given the established functional similarity of the two products and the same mechanisms of action across all conditions of use.

Indexed as

AnimalsAntineoplastic AgentsBinding, CompetitiveBiosimilar PharmaceuticalsBreast NeoplasmsCell Line, TumorErb-b2 Receptor Tyrosine KinasesFemaleHumansKineticsMice, NudeMolecular StructureNeoplasms, ExperimentalProtein BindingSignal TransductionStomach NeoplasmsAntineoplastic AgentsBiosimilar PharmaceuticalsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesTrastuzumabABP 980biosimilarbreast cancergastric cancertrastuzumab

Identifiers

PMID31696314
PMCPMC6834741
OpenAlexW2984412140

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.